Acute AppendicitisPhase 2/3NCT04030741
Non-operative Treatment of Acute Non-perforated Appendicitis
A Phase 2/3 study testing Meronem and flagyl and Appendectomy in people with Acute Appendicitis, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is curative but it is an invasive procedure done under general anesthesia with different risks and complications during and after operation… Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Meronem and flagyl and Appendectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2018to 1 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having PAS score >7will be included in the study.
Who cannot join
- Patient with suspicion of perforated appendicitis on the basis of generalized peritonitis and abscess formation on ultrasound.
- Patients with an appendicular mass, diagnosed by clinical examination and ultrasonography.
- Patient with previous non-operative treatment of acute appendicitis (recurrent appendicitis)
- Patients with C-reactive proteins > 40 mg/L.
- Patients with history of any previous abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Operative Treatment With Antibiotics Vs Surgery for Acute Non Perforated Appendicitis in Children: A Randomized Controlled Trial.
Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is curative but it is an invasive procedure done under general anesthesia with different risks and complications during and after operation, leading to disturbance of child daily routines and activities. Reported rates of perioperative complications are from 5% - 10%, with serious complications occurring in 1% to 7% of patients.
Children presenting with acute (<2 days) right iliac fossa pain with pediatric appendicitis score >7, with none of the following on ultrasonography: abscess formation, or loss of the echogenic sub-mucosal layer of the appendix or presence of an appendicolith or periappendiceal fluid collection will be labeled as having appendicitis.
After diagnosis we divided the patients into two groups.patients in group A will be treated with antibiotics and appendectomy is done for group B patients.
Read the detailed description
Acute appendicitis is one of the most common presenting conditions in pediatric emergencies. It has an estimated lifetime risk of about 8%. Although it commonly occurs in the second decade of life but 11.4% children are diagnosed with acute appendicitis in the pediatric emergency.
The rationale of my study is that limited local clinical trial is available regarding the efficacy of non-operative treatment with antibiotics vs operative treatment of acute non-perforated appendicitis in children.
All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having pediatric appendicitis score (PAS anexure 1) >7 will be included in the study.
All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Each patient will be evaluated and relevant data according to the predesigned questionnaire will be collected and documented. Age, duration of symptoms, body temperature,C-reactive protein, white blood cell, neutrophil concentrations, Ultrasound findings and PAS score will be noted at the time of admission. Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day divided into 2 divided doses) and metronidazole (20 mg/kg × 1 per 24 hours) for another 8 days. Supportive care will be given equally to all the patients as protocol of treatment with regular vital monitoring. Improvement or development of complications will be noted. Discharge criteria for both groups will be: afebrile for 24 hours, with or without oral antibiotics, adequate pain relief on oral analgesia assesd by visual analogue scale ( VAS) scale (anexure 2), tolerating a light diet, and mobile.
Failure of non-operative treatment will be defined if any one of the following is seen: abscess formation or complex peri-appendiceal fluid collection seen on ultrasonography, the need for surgery (due to worsening of symptoms evaulated by history, physical examination and repeat ultrasonography) within 48 hours, or recurrence of appendicitis within 3 months.
Patients with recurrence of symptoms of appendicitis (right iliac fossa pain with pediatric appendicitis score >7) after complete resolution previously with non-operated treatment, will be labeled as Recurrent appendicitis.All the data will be collected on a preformed questionnaire. Discharge criteria for both the groups will be: afebrile for 24 hours, with or without oral antibiotics, adequate pain relief on oral analgesia and tolerating a light diet. Patient will be kept on follow-up in group-A for duration of 3 month to 6 month. Patients will be kept on follow-up in Outdoor patients department once in a week till 3 months in group B.
ANNEXURE 1: Pediatric Appendicitis Score (PAS)
No Symptoms Score
- Right iliac fossa tenderness to cough, percussion, or hopping 2
- Migration of pain to Right iliac fossa 1
- Anorexia 1
- Fever (Temperature ≥38.0ºC/100.4ºF) 1
- Nausea or vomiting 1
- Tenderness over right iliac fossa 2
- Leukocytosis (WBC >10,000 ) 1
- Left shift (PMN >7,500 ) 1
Acute Appendicitis if score is >7
Anexure 2 Visual Analogue Scale
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 =Moderate pain 7-10 =Severe discomfort or pain or both
- Conditions
- Acute Appendicitis
- Being tested
- Meronem and flagyl, Appendectomy
- Keywords
- Acute Appendicitis., Pediatric Appendicitis Score (PAS)., Visual Analogue Scale (VAS) Score.
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meronem and flagylDrug
Also called Flagyl
meronem and flagy
AppendectomyProcedure or surgery
Appendectomy as treatment for acute appendicitis
| Study group | Role | What they receive |
|---|---|---|
| Meronem and flagyl | Active comparator | Children in Non-operative treatment (group A) Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day) divided into 2 divided doses) and metronidazole (20 mg/kg/day divided into 3 doses for another 8 days. Receives: Drug: Meronem and flagyl |
| Surgery (appendectomy) | Active comparator | Children in group B: appendectomy will b done and post operative single dose of antibiotics.
discharge after 24hour and Follow up after 1 week. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain relief assessed by visual analogue scale (VAS) score < 3
Measured: 24 hour
Afebrile
Temperature less than 98 Fahrenheit.
Measured: 24 hours
Food Tolerance
Child starts oral intake and had no symptoms after food intake.
Measured: 24 hour
Secondary outcomes (1)
Recurrence of symptoms of acute appendicitis
Child presented pain in right iliac fossa, nausea and loss appetite with PAS Score greater than 7.
on examination: Tenderness and Rebound tenderness
Measured: Within 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Sep 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After permission from the ethical review board (ERB), Children diagnosed with acute appendicitis and fulfilling the inclusion and exclusion criteria will be included in the study after taking informed consent from parents. All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Total sample size is 180 patiens and duration is 3 to 6 months.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Numeri, King Edward Medical University
- Investigators
- Paediatric surgery department, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030741
- Sponsor's protocol ID
- 201/RC/KEMU
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: First i have to publication of article then i want to make available for others.
Publications
Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
PubMed 27437029
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Operative Treatment With Antibiotics Vs Surgery for Acute Non Perforated Appendicitis in Children: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04030741
- Acronym / sponsor ID
- 201/RC/KEMU
- Conditions
- Acute Appendicitis
- Keywords
- Acute Appendicitis., Pediatric Appendicitis Score (PAS)., Visual Analogue Scale (VAS) Score.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gold Standard treatment of appendicitis is appendectomy but non-operative treatment of non-perforated appendicitis with antibiotics is also under trial. Although appendectomy is curative but it is an invasive procedure done under general anesthesia with different risks and complications during and after operation, leading to disturbance of child daily routines and activities. Reported rates of perioperative complications are from 5% - 10%, with serious complications occurring in 1% to 7% of patients.
Children presenting with acute (<2 days) right iliac fossa pain with pediatric appendicitis score >7, with none of the following on ultrasonography: abscess formation, or loss of the echogenic sub-mucosal layer of the appendix or presence of an appendicolith or periappendiceal fluid collection will be labeled as having appendicitis.
After diagnosis we divided the patients into two groups.patients in group A will be treated with antibiotics and appendectomy is done for group B patients.
Detailed description
Acute appendicitis is one of the most common presenting conditions in pediatric emergencies. It has an estimated lifetime risk of about 8%. Although it commonly occurs in the second decade of life but 11.4% children are diagnosed with acute appendicitis in the pediatric emergency.
The rationale of my study is that limited local clinical trial is available regarding the efficacy of non-operative treatment with antibiotics vs operative treatment of acute non-perforated appendicitis in children.
All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having pediatric appendicitis score (PAS anexure 1) >7 will be included in the study.
All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Each patient will be evaluated and relevant data according to the predesigned questionnaire will be collected and documented. Age, duration of symptoms, body temperature,C-reactive protein, white blood cell, neutrophil concentrations, Ultrasound findings and PAS score will be noted at the time of admission. Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day divided into 2 divided doses) and metronidazole (20 mg/kg × 1 per 24 hours) for another 8 days. Supportive care will be given equally to all the patients as protocol of treatment with regular vital monitoring. Improvement or development of complications will be noted. Discharge criteria for both groups will be: afebrile for 24 hours, with or without oral antibiotics, adequate pain relief on oral analgesia assesd by visual analogue scale ( VAS) scale (anexure 2), tolerating a light diet, and mobile.
Failure of non-operative treatment will be defined if any one of the following is seen: abscess formation or complex peri-appendiceal fluid collection seen on ultrasonography, the need for surgery (due to worsening of symptoms evaulated by history, physical examination and repeat ultrasonography) within 48 hours, or recurrence of appendicitis within 3 months.
Patients with recurrence of symptoms of appendicitis (right iliac fossa pain with pediatric appendicitis score >7) after complete resolution previously with non-operated treatment, will be labeled as Recurrent appendicitis.All the data will be collected on a preformed questionnaire. Discharge criteria for both the groups will be: afebrile for 24 hours, with or without oral antibiotics, adequate pain relief on oral analgesia and tolerating a light diet. Patient will be kept on follow-up in group-A for duration of 3 month to 6 month. Patients will be kept on follow-up in Outdoor patients department once in a week till 3 months in group B.
ANNEXURE 1: Pediatric Appendicitis Score (PAS)
No Symptoms Score
- Right iliac fossa tenderness to cough, percussion, or hopping 2
- Migration of pain to Right iliac fossa 1
- Anorexia 1
- Fever (Temperature ≥38.0ºC/100.4ºF) 1
- Nausea or vomiting 1
- Tenderness over right iliac fossa 2
- Leukocytosis (WBC >10,000 ) 1
- Left shift (PMN >7,500 ) 1
Acute Appendicitis if score is >7
Anexure 2 Visual Analogue Scale
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 =Moderate pain 7-10 =Severe discomfort or pain or both
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After permission from the ethical review board (ERB), Children diagnosed with acute appendicitis and fulfilling the inclusion and exclusion criteria will be included in the study after taking informed consent from parents. All the patients inducted in the study will be randomly divided into two groups: Non-operative treatment (group A) and operative treatment (group B), using computer generated number. Total sample size is 180 patiens and duration is 3 to 6 months.
| Arm | Type | Receives |
|---|---|---|
| Meronem and flagyl | Active comparator | Drug: Meronem and flagylChildren in Non-operative treatment (group A) Children in non-operative treatment group will be given intravenous meropenem (10 mg/kg/dose x IV x TDS) and metronidazole (20 mg/kg/day divided into 3 doses) for at least 48 hours. Once the child starts tolerating oral intake and becomes clinically improved, the treatment will be changed to oral ciprofloxacin (20 mg/kg/day) divided into 2 divided doses) and metronidazole (20 mg/kg/day divided into 3 doses for another 8 days. |
| Surgery (appendectomy) | Active comparator | Procedure: AppendectomyChildren in group B: appendectomy will b done and post operative single dose of antibiotics. discharge after 24hour and Follow up after 1 week. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 5 and 15 years of age of both genders admitted in the pediatric surgery emergency with having PAS score >7will be included in the study.
Key exclusion criteria (5 listed)
- Patient with suspicion of perforated appendicitis on the basis of generalized peritonitis and abscess formation on ultrasound.
- Patients with an appendicular mass, diagnosed by clinical examination and ultrasonography.
- Patient with previous non-operative treatment of acute appendicitis (recurrent appendicitis)
- Patients with C-reactive proteins > 40 mg/L.
- Patients with history of any previous abdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meronem and flagylAlso: Flagylmeronem and flagy | Drug | Meronem and flagyl |
| AppendectomyAppendectomy as treatment for acute appendicitis | Procedure or surgery | Surgery (appendectomy) |
Primary outcome
Pain relief
Time frame: 24 hour
Pain relief assessed by visual analogue scale (VAS) score < 3
Afebrile
Time frame: 24 hours
Temperature less than 98 Fahrenheit.
Food Tolerance
Time frame: 24 hour
Child starts oral intake and had no symptoms after food intake.
1 secondary outcome
Recurrence of symptoms of acute appendicitis
Time frame: Within 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Results publication: PubMed 27437029Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
- Maggiore Hospital, AUSL, Bologna, ItalyLink provided by the sponsor.
- Individual participant dataSharing planned: No. First i have to publication of article then i want to make available for others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paediatric surgery department principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Meronem and flagyl and Appendectomy in people with Acute Appendicitis, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04030741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.